Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SA16/0212 | Other Grant/Funding Number | The Dunhill Medical Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This pilot cluster-randomised controlled trial aims to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.
The risk of delirium, an acute disturbance in mental status and cognition that occurs commonly after cardiac surgery, increases sharply from the age of about 65 years. Its occurrence, even for one day, is associated with longer ICU and hospital stays, increased costs, and negative physical and cognitive outcomes at one year. In spite of previous prevention and intervention research, delirium incidence in the older cardiac surgical patient remains high (up to 72%).
ICU clinicians at Papworth Hospital have made observations suggesting that delirium could be reduced using a novel and unconventional strategy of bedside mirrors. Mirrors of any type are uncommon in ICU environments[1], but their occasional use by patients on our ICU has been reported by bedside clinicians and physiotherapists to result in:
Evidence from other sources supports mirrors' beneficial effect in these areas [2-10], but mirror use has never to our knowledge been explored for the reduction of delirium. This pilot study seeks to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirrors Intervention | Experimental | Patients allocated to Mirrors will receive a structured, protocol-driven bedside mirrors intervention as part of their postsurgical ICU care. This intervention will commence as soon as all anaesthetic agents have been switched off and the patient is awake following surgery unless considered clinically inappropriate. |
|
| Standard Care | No Intervention | Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirrors Intervention | Other | Coaching in the use of two types of mirrors to support mental status and attention, physical mobility, and sense of body awareness and ownership, as well as patient dignity and privacy in self-care. To be administered at set times and in a standardised way by ICU nursing and physical therapy teams. |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium incidence | Delirium will be measured twice daily, using the Confusion Assessment Method for the ICU (CAM-ICU). | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium time of onset | This is the patient's first occurrence of delirium, as measured using the CAM-ICU, counted in number of days from admission to ICU. | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| Delirium duration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Alain Vuylsteke, MD | Papworth Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papworth Hospital NHS Foundation Trust | Papworth Everard | Cambridgeshire | CB23 3RE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19300071 | Background | Freysteinson WM. The use of mirrors in critical care nursing. Crit Care Nurs Q. 2009 Apr-Jun;32(2):89-93. doi: 10.1097/CNQ.0b013e3181a27b3d. | |
| 18202215 | Background | Vanhaudenhuyse A, Schnakers C, Bredart S, Laureys S. Assessment of visual pursuit in post-comatose states: use a mirror. J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):223. doi: 10.1136/jnnp.2007.121624. No abstract available. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2016 | |
| Reset | May 12, 2016 | |
| Release | Jun 21, 2016 | |
| Reset | Aug 2, 2016 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2016 | May 12, 2016 | |||
| Jun 21, 2016 |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| D019965 | Neurocognitive Disorders |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
This is the total number of ICU days with delirium, as measured using the CAM-ICU |
| Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| Mental Status | Measured from Features 1 & 3 of CAM-ICU | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| Attention | Measured from Feature 2 of CAM-ICU | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| Functional Independence | Measured using Barthel Index | Assessed at 12 weeks after surgery |
| Perceptual disturbances about the body and dissociative symptoms | Measured using interview described in previous work (Morgan et al., Biol Psychiatry, 2011) | Assessed at 12 weeks after surgery |
| Health-Related Quality of Life (HRQoL) | Measured using EQ-5D | Assessed at 12 weeks after surgery |
| Length of ICU and hospital stay | This is the patient's length of stay in ICU and hospital, in number of days from admission date until discharge date. | Assessed at hospital hospital discharge |
| Mortality | This is patient mortality from admission to ICU until 12 weeks after surgery. | Assessed at 12 weeks after surgery |
| Factual memories from ICU | Measured using the ICU Memory Tool (Jones et al., Clin Intensive Care, 2000) | Assessed at 12 weeks after surgery |
| Intraclass correlation coefficient (ICC) for time clusters | This is a measure of the within-cluster correlation necessary for calculating sample size necessary for a definitive trial if warranted | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| Acceptability of the intervention | This is the number of instances when the intervention was considered appropriate by clinicians and accepted and used by patients, divided by total recorded indicated instances. | Assessed from day of ICU admission after surgery until day of ICU discharge (or until 12 weeks after surgery, whichever comes first) |
| 9265610 | Background | Tabak N, Bergman R, Alpert R. The mirror as a therapeutic tool for patients with dementia. Int J Nurs Pract. 1996 Sep;2(3):155-9. doi: 10.1111/j.1440-172x.1996.tb00042.x. |
| 10376620 | Background | Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available. |
| 25493277 | Background | Tung ML, Murphy IC, Griffin SC, Alphonso AL, Hussey-Anderson L, Hughes KE, Weeks SR, Merritt V, Yetto JM, Pasquina PF, Tsao JW. Observation of limb movements reduces phantom limb pain in bilateral amputees. Ann Clin Transl Neurol. 2014 Sep;1(9):633-8. doi: 10.1002/acn3.89. Epub 2014 Sep 30. |
| 27733826 | Derived | Giraud K, Pontin M, Sharples LD, Fletcher P, Dalgleish T, Eden A, Jenkins DP, Vuylsteke A. Use of a Structured Mirrors Intervention Does Not Reduce Delirium Incidence But May Improve Factual Memory Encoding in Cardiac Surgical ICU Patients Aged Over 70 Years: A Pilot Time-Cluster Randomized Controlled Trial. Front Aging Neurosci. 2016 Sep 28;8:228. doi: 10.3389/fnagi.2016.00228. eCollection 2016. |
| Aug 2, 2016 |